MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF® I90, ASPIRATING ABLATOR 90°; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLO RF® I90, ASPIRATING ABLATOR 90°
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 07/28/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-9831 probe electrode fell off.This occurred during use in a case with no patient effect.All fragments removed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical forces.Dfu-0242-eo: do not use excessive force when inserting or removing the rf probe.Do not insert the rf probe into an obstructed passageway.Patient injury and or product damage may occur.The complaint allegation could not be confirmed as the device was not received for investigation.

• Brand Name: APOLLO RF® I90, ASPIRATING ABLATOR 90°
• Common Device Name: ELECTROSURG CUT/COAG DEVICE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22782802
• Report Number: 1220246-2025-03433
• Device Sequence Number: 9869595
• Product Code: GEI
• UDI-Device Identifier: 00888867428492
• UDI-Public: 00888867428492
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: APOLLO RF® I90, ASPIRATING ABLATOR 90°
• Device Catalogue Number: AR-9831
• Device Lot Number: 15401364
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown